RATiFY
Research type
Research Study
Full title
Response adapted incorporation of Tislelizumab into the front-line treatment of older patients with Hodgkin lymphoma
IRAS ID
1005530
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Eudract number
2022-003677-37
Clinicaltrials.gov Identifier
Research summary
RATiFY is a trial for patients age 60 years or older with Hodgkin lymphoma who have previously not received any treatment for their lymphoma. In younger people Hodgkin lymphoma can usually be cured with first-line chemotherapy treatment, but it becomes more difficult to treat in older people because it is more difficult for them to tolerate side effects of treatment. We currently don't know what the best combination of treatment is for elderly patients. Immunotherapy in combination with chemotherapy may prove to be an effective form of treatment with tolerable side effects.
Immunotherapy is treatment that activates the immune system against cancer cells. In this trial we will look at including an immunotherapy drug called tislelizumab to see if it is effective and well-tolerated. Similar immunotherapy drugs are already used for Hodgkin lymphoma that has not responded to or has come back after treatment. They are usually better tolerated than chemotherapy, although they do have some side effects.
All patients will receive 3 doses of tislelizumab at 21-day intervals then have a scan to assess how their disease has responded to the treatment. Some patients with ‘early stage’ lymphoma with a very good response to the treatment will receive radiotherapy and go on to have further tislelizumab for up to 2 years, but no chemotherapy. All other patients will receive tislelizumab with chemotherapy for between 2 and 6 28-day cycles after the first 3 doses. Some patients will also receive radiotherapy depending on which parts of their body are affected by the lymphoma. Patients will attend hospital for regular appointments and tests including blood tests and scans. Patients will be followed up for 2 years from the start of their trial participation then their disease status will be checked on annually until the trial ends.
RATiFY will recruit patients in 20 NHS hospitals throughout the UK. The study is funded by BeiGene, who are providing tislelizumab free of charge.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
24/EM/0163
Date of REC Opinion
28 Aug 2024
REC opinion
Further Information Favourable Opinion